The investigators plan to initiate a prospective, multicenter, phase II study, recruiting 30 patients with advanced colorectal cancer patients with liver metastasis who have not received prior treatment. This study plans to reconstruct intestinal microecology through fecal microbiota transplantation (FMT), and combine with QL1706+Bevacizumab+XELOX to enhance the anti-tumor immune effect at the same time, thereby improving the prognosis of colorectal cancer patients with liver metastasis.
Histological or cytological confirmed advanced colorectal cancer with liver metastasis.
Signed written informed consent.
Have not received anti-tumor treatment.
According to the investigators assessment, at least one measurable target lesion defined by RECIST v1.1.
Suffered from other malignancies in the past 5 years, excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ and papillary thyroid carcinoma.
Patients requiring elective surgery during the trial.
Patients who cannot take oral drugs, or have conditions that the investigator determines to significantly affect gastrointestinal absorption, such as chronic diarrhea, intestinal obstruction, etc., and are not suitable for treatment.
Patients during pregnancy (positive pregnancy test) or lactation.
Single group
FMT+QL1706+Bevacizumab+XELOX
Combination productParticipants will receive FMT combined with QL1706+Bevacizumab+XELOX for 6 cycles. If there is no progression of the disease after 6 cycles of the first-line treatment, then patients will enter the maintenance treatment stage. The therapy of maintenance treatment stage was at the discretion of the investigator.
Objective Response Rate (ORR)
Objective response rate will be assessed by investigators.
Median Progression-Free Survival (mPFS)
Observation for mPFS will be recorded until the end of follow-up after the start of 1st cycle of treatment.
Median Overall Survival (mOS)
The time from the first treatment to death from any cause.
6-Months Progression-Free Survival Rate (6month-PFS)
The proportion of patients whose disease did not progress 6 months after treatment
12-Months Progression-Free Survival Rate (12month-PFS)
The proportion of patients whose disease did not progress 12 months after treatment
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Hua Jiang
Lead sponsor
Changzhou No.2 People's Hospital
Sponsor institution
